Medical System Having Plug And Play Function

ABSTRACT

A medical system is disclosed, which can be useable in particular for monitoring and/or controlling at least one bodily function of a user. The medical system comprises a control device and at least one medical user element embodied separately from the control device. The medical user element and the control device are designed to exchange data wirelessly. The medical system is designed to enable an automatic assignment step, wherein an exchange of personal data between the medical user element and the control device is enabled by the automatic assignment step. The medical system is furthermore designed to automatically initiate the automatic assignment step by means of an assignment coupling between the medical user element and the control device. The medical system is furthermore designed to enable a separation of the assignment coupling for medical operation of the medical system after the assignment step.

REFERENCE

This application is a continuation of PCT/EP2010/053459 filed Mar. 17,2010 which is based on and claims priority to European PatentApplication No. EP 09 155 892.4 filed Mar. 23, 2009, which are herebyincorporated by reference.

FIELD

This disclosure relates to a medical system comprising a control deviceand at least one medical user element embodied separately from thecontrol device, and also to a method for operating the medical system.Medical systems and methods of this type are used in particular formonitoring and/or controlling at least one bodily function of a user,for example for continuously monitoring an analyte concentration in abody fluid. Fields of use can be found in particular in the hospitalarea, in the care area or in the area of home care and/or of homemonitoring. However, other fields of use are also possible, inprinciple.

BACKGROUND

Numerous examples of medical systems having a plurality of componentsembodied separately from one another which are intended to communicatewith one another are known from medical technology. The plurality ofcomponents comprise at least one medical user element and at least onecontrol device. The user element can be a personal medical element, forexample having a measurement function and/or a medication function. Userelements of this type are generally driven and/or read by at least onecontrol device. The control device can provide a user interface, forexample, by means of which a user (for example a patient or a healthyperson) can control the system or can interrogate information of thesystem. Examples of medical systems of this type are presented in US2005/0113886A1 Implantable medical system with long range telemetry byFischell et al. (May 26, 2005); U.S. Pat. No. 6,738,670B Implantablemedical device telemetry processor by Almendinger et al. (May 18, 2004);and U.S. Pat. No. 6,752,155B2 Tactile feedback for indicating validityof communications link with an implantable medical device by Behm (Jun.22, 2004).

A challenge in the case of medical systems of this type consists in theconnection of the individual components of these systems. In this case awireless data connection, that is to say a connection in which a dataexchange is made possible in the first place not via artificial lines(such as, for example, cables, interfaces or plugs), rather the dataexchange takes place by means of electromagnetic waves, is oftenpreferable to a wire-based data exchange for reasons of practicability.In the case of a wireless data exchange, however, in medical systems theparticular challenge consists in the fact that, on the one hand, aninteroperability of the individual components has to be ensured withouta user (for example a patient of childhood age or older persons) havingto perform complex technical measures for this purpose. On the otherhand, it is necessary to ensure that sensitive personal data such ascontrol commands which are communicated to a user element or measurementdata which are communicated to the control device by the user elementreach the correct addressee. Thus, in particular, the operability, whichcan be understood to mean a plug-and-play interoperability, for example,must not be implemented so widely that new devices are automaticallyintegrated into the medical systems which are not intended to belong tothe latter, such as user elements of other users, for example. In thiscase, plug-and-play concepts are generally understood to mean conceptsin which new hardware components can be added to systems and arerecognized by the system, without a separate driver having to be loadedfor this purpose. This can lead, for example, to personal measurementdata being revealed in an undesirable manner, or even to the erroneousaddressing of control commands, with possibly fatal medicalconsequences. For this purpose, standards which serve this purpose andwhich are combined under IEEE 11073, for example, are already known frommedical technology.

A particular difficulty is posed in the case of medical systems whichhave at least one diagnostic function, for example in diagnosticmeasuring systems. Examples of such medical systems are so-calledcontinuous monitoring glucose systems, which are already commerciallyavailable at the present time. In this case, in current systems, theindividual components, such as, for example, disposables, re-usables andalso read-out and data management components, are generally soldtogether in a set. However, it is also possible for system parts to beprocured subsequently and put into operation later. In this case, theindividual components are individually put into operation and, ifappropriate, coordinated with one another or allocated to one another bythe user.

Particularly in the case of diabetes self-monitoring systems, but alsoin the case of other diagnostic measuring systems, consumable materialsare generally used, such as sensors, for example. Said sensors carry inpart complex, specific information which they have to convey to thetarget system, for example a control device, during use. On the otherhand, collected data records are generally sent to peripheral computersystems for more extensive conditioning or processing. Such activitiesgenerally require a high degree of organization and coordination by theoperator.

Particularly in diagnostic measuring systems of this type, but also indifferently configured medical systems and primarily with the advent ofnew multi-sensor systems (for example body area networks, BANs), thedevelopment of a plug-and-play technology has hitherto either still notbeen introduced at all or been developed only insufficiently. In manycases this has the effect that users, who are generally not educated inthe technological field, have difficulties in dealing with the complextechnology unless the users are guided and trained in a manner involvinga high outlay. However, such guidance and training requires extensiveefforts on the part of the system supplier with regard to theconfiguration of user manuals or training measures.

In many cases there is a further problem with consumable materials, suchas, for example, test strips or other types of sensors. Here, forprocess-technological reasons, in many cases it is necessary todetermine calibration data and convey them to the consumable material inthe form of a separate data carrier. These data have to be transmittedto the measuring or evaluation device when the consumable material isstarted up, such that said device can, if appropriate, carry out acorrection of the measurement values determined. In many cases, however,data and consumable material are not necessarily assigned physically toone another, such that the consumable material and the data can be mixedup upon the re-initialization of system components, but to an increasedextent also when newly equipping a system with consumable material. Thiscan lead to incorrect measurement results and possibly serious medicalconsequences.

Furthermore, problems can occur in components that communicate by radiotechnology. As explained above, such connections between the individualcomponents are not unambiguously defined and not unambiguously visible,as is possible particularly in the case of networked connections orconnections connected by cables or optical links. Radio connections arepossible for example through or across natural obstacles such as wallsor the like. Many modern radio networks are set up by definition ontheir own authority by virtue of potential network componentsindependently identifying themselves and providing possible dataexchange. This means that components of the networks can communicatewith one another without the user having to intervene actively for thispurpose. In this case, however, generally no specific user data, that isto say private data, in particular, are exchanged yet. If such personalor private data are intended to be transmitted, then generally aso-called authentication has to be carried out beforehand. This can beeffected for example by a manual inputting of numbers and/or codesdirectly into the relevant components which are intended to communicatewith one another. What is problematic about this authentication,however, is that it presupposes an active and complex activity on thepart of the user, which can be susceptible to errors particularly in thecase of use by older patients or children. Thus, particularly in thecase of long series of numbers being input, which is associated with aconsiderable complexity anyway, incorrect inputs can easily occur, whichin turn can lead to malfunctions of the system.

These malfunctions increase the risk for medical networks, which can bebeset with a risk anyway for example on account of numerouspossibilities for incorrect operation. Thus, by way of example, theinsertion of consumable material and of auxiliary materials such asbatteries or memory components, for example, by a user can be associatedwith incorrect operation, for example polarity reversal or incorrectcontact-making. This can lead to malfunctions and damage in the medicalnetwork. Generally, therefore, the start-up of individual systemcomponents or entire networks necessitates comprehensive, oftendifficult to understand documentation, which causes costs, requiresspace and generally is not noticed or read by the user at all, or onlyin an error situation.

Therefore, it is desirable to provide a medical system which at leastsubstantially avoids the disadvantages of known medical systems. Inparticular, the medical system should be able to independently identifynew system components, in particular new medical consumable materials,and to integrate them securely and reliably with the least possibleeffort for the user.

SUMMARY

A medical system should be understood generally to mean a system whichcomprises at least two components which, in particular, can beconfigured spatially separately from one another and which has at leastone medical, in particular therapeutic and/or diagnostic, function. Inparticular, the system can be one which serves for monitoring and/orcontrolling at least one bodily function of a user. In this case, abodily function should generally be understood to mean, in principle,any desired function and/or property of the body of the human or animaluser, for example a physically and/or chemically measurable propertysuch as e.g. an analyte concentration in a body fluid and/or a bodilyfunction which is associated with an actuator system, for example avalve function, a muscle function or a discharge of specific chemicalsubstances. Various examples are discussed in greater detail below. Theuser can be, in principle, a patient, but also, in principle, healthypersons. In this case, at least one component of the medical system, inparticular the user element discussed in greater detail below, ispreferably intended to be carried by the very user whose bodily functionis intended to be monitored and/or controlled, preferably directly on orin the body.

The medical system comprises a control device. Although many medicalsystems comprise only a single control device, some medical system cancomprise a plurality of control devices of this type, which can likewisecommunicate. The control device can be configured in portable fashion,in particular, such that it can be carried by the actual user.Accordingly, the control device can be dimensioned in terms of itsdimensions in order to be carried for example in a user's pocket.

In this case, a control device should be understood to mean, inprinciple, a device which has at least one user interface via which auser—in some embodiments without the aid of further electroniccomponents—can input data and/or commands into the medical system and/orcan read out information from the medical system. By way of example, thecontrol device can comprise for this purpose one or more operatingelements, for example one or more keys, one or more touch screens, voiceinputs, track balls, slides, levers, dials, scanners or other types ofoperating elements or combinations of the stated or other types ofoperating elements. Furthermore, the control device, alternatively oradditionally, can comprise one or more indicator elements, for examplein order to communicate information to the user optically and/oracoustically and/or tactically (for example by vibrations). By way ofexample, it can comprise at least one indicator element in the form of adisplay, for example a segmented display and/or a matrix display. Thelatter can also be combined with operating elements, for example in theform of a touch screen.

The control device can comprise a simple blood glucose measuring deviceand/or also one or more devices originating from non-medical areas, suchas, for example, mobile radio devices, PDAs or lifestyle or sportsdevices, such as, for example, pedometers, pulse meters or the like. Thecontrol device should therefore be designed to enable a user to inputcommands into the medical system, in particular for controlling themedical user element explained in even greater detail below, and/or forreading out information, for example measurement data of the medicaluser element, via the control device.

The medical system furthermore has at least one medical user elementembodied separately from the control device. A medical user elementshould be understood to mean any desired device having a medicalfunction which can be carried by the user. This carrying can take placedirectly on or in the body. The medical function can comprise, inparticular, a therapeutic and/or a diagnostic function. By way ofexample, this function can comprise a measurement function for detectingspecific data, in particular for detecting data which are characteristicof the user, for example data which are associated with a bodilyfunction. By way of example, they can be measurement data of an analyteconcentration in a body fluid of the user. Alternatively oradditionally, the medical function can comprise a medication function,for example an administration of a specific medicament at specificpoints in time and/or in predefined amounts and/or concentrations. Byway of example, the function of an insulin pump can be involved. Onceagain alternatively or additionally, the medical function can alsocomprise an actuator function, for example a pacemaker function and/or avalve function. Various examples are explained in greater detail below.The medical user element can comprise at least one consumable elementsince the advantages of the medical system as described below aremanifested positively in particular when consumables are exchanged.

The medical user element and the control device are designed to exchangedata wirelessly. In this case, the term data can generally subsumeinformation and/or commands, for example measurement data and/or controlcommands. In this case, a wireless data exchange should be understood tomean a data exchange in which data processing does not have to be set upby the user by means of specific hardware, such as a cable, for example;rather, the wireless data exchange is preferably intended to take placeby means of electromagnetic waves and/or conductive guide mechanismswhich are transmitted directly or else, for example, via a body networkincluding body parts of the user as conducting elements. The wirelessdata exchange can comprise a data exchange via radio, preferably a dataexchange in which the control device and the medical user element do nothave to be arranged in a specific orientation with respect to oneanother, such as, for example, in the case of an infrared dataconnection. In principle, however, other types of wireless data exchangecan also be implemented, for example conductance on/in the body orcapacitive, dielectric displacement currents, for example in the form ofso-called body area networks (BANs). Data exchange can be via a radioconnection, such as a far-field radio connection.

The medical system is designed to enable an automatic assignment step,which enables personal data to be exchanged between the medical userelement and the control device. In this context, automatic should beunderstood to mean, in particular, that the assignment step can takeplace without complex user actions, for example without the inputting ofcomplex alphanumerical codes, without the exchange of memory chips orsimilar data carriers, by the user. The assignment step is therefore amethod step that enables a communication between the control device andthe medical user element in which even sensitive, personal data can beexchanged. Before the at least one assignment step is actually carriedout, the medical user element and the control device can communicate,for example by virtue of a simple recognition signal being communicated,which signals purely the presence of the user element in the vicinity ofthe control device, or vice versa. In this way, before the assignmentstep, for example, a provisional communication can take place by meansof which, for example, general data can be exchanged. In principle, thisprovisional communication can optionally also extend to an extendedinteroperability. An extended interoperability (IO) can be understood tomean the software protocol level in a basic technology, for exampleBluetooth, for example having a fixed carrier frequency, e.g. 2.45 GHz.However, interoperability could also be extended in such a way that thehardware can also be automatically adapted. By way of example, a radiocarrier frequency can be automatically adapted. By way of example, achangeover can take place from Bluetooth to 1.9 GHz GSM mobile radio orto 433 MHz of a different so-called ISM band. These examples show that,in principle, there are a large number of possibilities for configuringa provisional communication in which no personal data are exchanged yet.

Personal data, the exchange of which is intended to be possible onlyafter the assignment step has been carried out successfully, should beunderstood generally to mean data and/or control commands which areessential for the functionality of the medical system, for example for atherapeutic and/or diagnostic function of a specific medical userelement. They can be, for example, measurement data which were detectedat this specific user using the medical system and/or the specificmedical user element, and/or control commands which are intended for aspecific medical user element and which are not intended to becommunicated to other medical user elements. The classification of dataas personal data can be defined for example in one or more components ofthe medical system, for example in the control device and/or in themedical user element. By way of example, the control device can bedesigned in such a way that specific control commands are classified init as personal data which are permitted to be communicated, only afterthe assignment step has been carried out successfully, to a specificuser element with which the assignment step was carried out. Conversely,by way of example, it is possible to classify specific measurement dataor types of measurement data in a medical user element as personal data,such that these measurement data can be communicated to the controldevice for example only when an assignment step has been successfullyended with this specific control device.

The exchange of the personal data between the medical user element andthe control device can be effected uni-directionally in one of the twodirections, that is to say, for example, from the control device to themedical user element or vice versa, or bi-directionally. Thus, it ispossible to communicate measurement data from the medical user elementto the control device and control commands from the control device tothe medical user element. However, other configurations are alsopossible.

The medical system is designed according to the invention toautomatically initiate the automatic assignment step by means of anassignment coupling between the medical user element and the controldevice. This means that the assignment step is successful if the medicalsystem, preferably both the control device and the medical user element,recognizes that the assignment coupling has been produced. In this case,as will be explained in even greater detail below, an assignmentcoupling should be understood to mean a predefined handling of thecontrol device and of the medical user element by the actual user and/orsome other person which differs from a handling in normal operation, forexample medical operation, in which the medical system regularlyoperates and in which the personal data are exchanged. In other words,the assignment coupling is intended to comprise a deliberate handling ofthe medical user element and of the control device by the user and/orsome other person which does not occur randomly or occurs randomly onlywith very low probability in medical operation and by means of which theassignment step is initiated. Said assignment coupling is typicallyintended not to comprise any complex handling at all, such as, forexample, the exchange of memory elements or the inputting ofalphanumeric characters.

The conditions under which an assignment takes places can be fixedlypredefined. Said conditions can comprise, as specified above, forexample the fixedly predefined assignment coupling. Alternatively oradditionally, the conditions under which the assignment takes place,that is to say the conditions for an automatic assignment step, can alsobe configured in variable fashion. By way of example, said conditionsunder which an assignment takes place, and which can also be designatedas “pairing conditions”, can be dependent on external circumstancesand/or a state of the user. If a critical state is detected, for examplehypoglycemia, then it is possible for the medical user element to bedesigned to enable a facilitated assignment with one or more controldevices, for example one or more additional control devices. By way ofexample, upon detection of a critical state, the user element can bedesigned automatically to communicate with any control device in itsvicinity which meets specific conditions and is in a “physician mode”and also to exchange personal data.

The medical system is furthermore designed to enable a separation of theassignment coupling for medical operation of the medical system afterthe assignment step, that is to say after the assignment step has beensuccessfully carried out. This means that the assignment coupling isproduced only temporarily, and can then subsequently be separated formedical operation. Consequently, in medical operation, in which thepersonal data are exchanged, the assignment coupling no longer exists;rather, preferably exclusively the exchange of the personal data takesplace via the wireless data connection, in which case, however, by wayof example, an assignment identification exchanged during the existenceof the assignment coupling can continue to be used. In this case,medical operation should be understood to mean the normal operation ofthe medical system, for example diagnostic operation and/or therapeuticoperation, for example measurement operation. In this operation, themedical data can be exchanged.

The medical system proposed thus enables, in a simple manner,plug-and-play operation in which new medical user elements can beintegrated into the medical system or can be exchanged from said medicalsystem. As a result of the assignment coupling that initiates theassignment step, an initiation of the exchange of personal data ispossible in a simple and secure manner, without necessitating a complexhandling by the user, such as, for example, the inputting ofalphanumeric codes and/or the exchange of memory elements. However, suchactions can additionally be provided.

The medical system thus enables the communication between the controldevice and the medical user element, wherein firstly the two componentsare connected to one another in a specific manner in the automaticassignment step, preferably without the user in this case having toinput data or exchange a code or having to press keys. An authenticationcan take place automatically between the control device and the medicaluser element, such that a pairing between the control device and themedical user element can be brought about by the assignment step bymeans of the assignment coupling brought about deliberately by the user.The authentication, which enables personal data subsequently to beexchanged, can take place automatically between the components, suchthat a data exchange can subsequently take place without any furtherpairing process, in contrast to known medical systems. Thus, when amedical user element is started up, for example when a sensor is newlystarted up, an automatic assignment step in the form of an automaticpairing can take place, which enables the medical user element and/orthe user to authenticate themselves.

Optionally, the medical system can also be configured in such a way thata user actually carries a code, for example on an RFID transponder.After a defined assignment coupling, that is to say after successfulpairing, for example in accordance with one of the procedures describedin even greater detail below, for example establishment of proximity, apairing via a body area network, an active confirmation or the like, themedical system, for example the control device, then knows said code andcan exchange data. A module can also know a plurality of codes of thistype.

Certain embodiments of the medical system concern, in particular, theconfiguration of the assignment coupling. This assignment coupling,which enables an automatic pairing can comprise a deliberate action onthe part of the user and/or some other person which is necessary forbringing about the assignment coupling and/or for initiating theassignment step. In certain embodiments, with regard to the performanceof this action, no distinction is drawn between the cases where thetreatment is performed by the actual user or by some other person, forexample a physician, pharmacist or medical technician. Thesepossibilities are intended to be encompassed by the term performance ofthe action by the user. The deliberate action is intended, inparticular, as explained above, to be configured in a simple manner andwith little susceptibility to errors and is intended to differ fromother actions which occur in medical operation of the medical system orwhich could be carried out unwittingly. In particular, no inputting ofalphanumeric characters by the user and/or exchange of memory elementsand/or inputting of data and/or codes and/or actuation of keys should benecessary.

In a first possible configuration, the assignment coupling can comprisea temporary coupling alignment between the medical user element and thecontrol device, wherein the coupling alignment is different than analignment in medical operation and also than a random alignment of thecomponents of the medical system. This coupling alignment can comprise aspecific positioning and/or spatial orientation of the control deviceand of the medical user element with respect to one another. By way ofexample, this coupling alignment can comprise a specific spatialproximity, for example an undershooting of a minimum distance, throughto a (non-random) physical contact between the medical user element andthe control device. This obtaining of a spatial proximity for bringingabout the coupling alignment can also be designated as “pairing by nearclosing”. This coupling alignment can be configured in such a way thatit does not occur during normal handling of the medical system, suchthat no random, undesired coupling alignment is possible. Examples ofsuch a coupling alignment are presented below.

Alternatively or additionally, the assignment coupling can also comprisea temporary physical coupling connection between the medical userelement and the control device, which can be brought about andsubsequently disconnected again in a targeted manner by the user. Thistemporary physical coupling connection can be effected, for example, viaa coupling interface, a docking station, a wire-based connection, awireless near-field connection or an infrared connection. In contrast tothe wireless connection for exchanging the personal data in medicaloperation, which can be effected in a manner not involving directelectrical coupling, in the case of this temporary physical couplingconnection a temporary direct electrical coupling can also be effected,for example via a coupling cable, a coupling plug or the above mentioneddocking station. Thus, the user element and the control device can beinserted into a docking station successively or simultaneously, suchthat, by means of this handling, the coupling connection is produced andthe assignment step is initiated. The medical user element and thecontrol device can be unambiguously assigned to one another.

In this case, a docking station should be understood to mean, inprinciple, a stationary device which can have, for example, a stationarypower supply and/or also a dedicated, portable power supply, which makesit possible, for example, to exchange authentication information betweenthe medical user element and the control device and/or to exchangeassignment identifications in another way. A portable configuration ofthe docking station is also possible, in principle. Devices fortransport and/or for energy supply, for example in the form of acharging part, of the medical user element and/or of the control devicecan also be wholly or partly embodied as a docking station and/or becontained in a docking station.

As an alternative or in addition to the docking station, a temporarywire-based connection can also be produced, for example by a usertemporarily connecting the medical user element and the control deviceby means of a cable. An infrared connection can comprise a deliberatealignment of the medical user element relative to the control device bythe user, such that infrared interfaces of these elements can in eachcase communicate with one another. Afterward, this infrared connectioncan be disconnected again, for example by the medical user element andthe control device being positioned in such a way that an infraredcommunication can no longer take place.

Once again alternatively or additionally, the wireless near-fieldconnection can comprise a connection via a radio frequency interfacewhich only enables data to be exchanged over short distances, forexample distances of a minimum distance or less, for example a few 10cm. By way of example, transmission techniques typically used in RFIDtechnology can be used, which, however, are not suitable subsequentlyfor the exchange of personal data. By way of example, the medical userelement can comprise an RFID chip and/or a transponder which can be readby a reader of the control device only in a specific coupling alignmentbetween the medical user element and the control device, wherein theRFID connection can preferably subsequently be disconnected again. Thesubsequent exchange of personal data in medical operation then no longertakes place via the abovementioned RFID connection or near-fieldconnection, but rather via the wireless connection described above. Inthis configuration or else in other configurations, both the medicaluser element and the control device should therefore have at least twointerfaces, one interface for carrying out the automatic assignment stepand one interface for the wireless data exchange of at least thepersonal data during medical operation.

As an alternative or in addition to the above mentioned possibilities,the assignment coupling can also comprise an indirect assignmentcoupling via at least one coupling element. In this case, the assignmentcoupling is intended to be configured in such a way that the medicaluser element and the control device can be temporarily connected to thecoupling element simultaneously or successively in order to initiate theassignment step. In this case, a coupling element can be understood tomean, in principle, any desired article to which the medical userelement and the control device can be connected simultaneously orsuccessively, in particular in order to exchange one of a plurality ofassignment identifications. In this way, the assignment in theassignment step, for example an authentication, can be effectedindirectly via the coupling element. The coupling element can compriseand/or provide, for example, the temporary physical coupling connectiondescribed above. The coupling element can be for example an inanimatearticle, but can also comprise for example one or more body parts of theuser via which signals can be exchanged, for example. As will beexplained in greater detail below, biometric characteristic data in theform of biometric features can also be exchanged via a body part of theuser or transmitted by the body part of the user simultaneously orsuccessively both to the medical user element and to the control device,such that the medical user element and the control device can beassigned to one another.

The medical system can be designed to exchange at least one assignmentidentification via the assignment coupling (for example the couplingelement mentioned above). This exchange can take place for exampleuni-directionally from the control device to the medical user element,or vice versa, or bi-directionally. Alternatively or additionally, theexchange can also comprise for example a third element, such as theabove-mentioned coupling element, for example, which provides theassignment identification. In this case, both the control device and themedical user element have the corresponding or identical assignmentidentification, such that these two components can be unambiguouslyassigned to one another.

In this way, later a single data manager in the form of the controldevice can be provided, which can communicate in a targeted manner withany additional medical user elements, for example measuring devices,used by the patient, in such a way that firstly in the assignment stepdata in the form of the assignment identification are communicated tothe data manager, which enable the latter to recognize in later normaldata exchange processes during medical operation that said dataoriginate from the specific medical user element or from the specificuser of said medical user element. In this way, one and the same datamanager can also interact with a plurality of medical user elements,wherein the exchanged data, for example the personal data, can always beunambiguously assigned to a specific medical user element. This greatlyincreases the handling security of the medical system, since firstly thecontrol device can distinguish data of different medical user elementsand since secondly an inadvertent linking of other medical userelements, for example of third-party users, into the medical system, forexample a network of the medical system, can be avoided by means of theabove mentioned assignment step. The control device can be designed toassign, in this medical operation, data, in particular personal data,communicated by the medical user element on the basis of the assignmentidentification to said medical user element and, for example, to performcorresponding further steps such as, for example, data evaluation,storage of the data or the like. However, a targeted linking ofthird-party persons who are deliberately authorized into one or moremedical systems could also be effected, or a plurality of medicalsystems could be partly identical in respect of components. Thus, acontrol device could also be part of a plurality of medical systemswhich can be used separately. Thus, a plurality of users, for example amarried couple, could use a common control device, for example a commondata manager. The latter can then be used in a first medical system of afirst user and in a second medical system of a second user. The firstmedical system and the second medical system can comprise differentmedical user elements. By means of the respective assignmentidentification, the current operation can then be assigned to a specificmedical system, such that, for example, at any point in time at whichpersonal data are exchanged, it is possible for the control device torecognize whether said personal data are to be assigned to the firstmedical system or to the second medical system. Accordingly, anevaluation and/or processing of the personal data can be effectedseparately, such that, for example, the different users can in each caseonly access their personal data and/or that confusion and/or mixing-upof the personal data is precluded.

A further advantageous configuration of the medical system concerns theassignment coupling already mentioned above, which enables theassignment step. As explained above, the assignment coupling cancomprise a temporary, predefined coupling alignment between the medicaluser element and the control device. In some embodiments, it isdesirable if said coupling alignment is supported by an external shapingof the medical system or of individual components of the medical system,such that, by way of example, a user unambiguously recognizes how thecoupling alignment has to be effected. In this way, by means of anexternal shaping imparted to the medical system, it is possible to avoidan operating error when bringing about the coupling alignment.Accordingly, in some embodiments it is desirable if the medical userelement and the control device are designed in terms of their externalshape to enable a defined temporary coupling alignment between themedical user element and the control device. In some embodiments, thecontrol device has a housing having at least one depressioncorresponding to an external shape of the medical user element. In thiscase, the medical user element, for the purpose of producing theassignment coupling, is intended to be able to be temporarily introducedinto the depression. Alternatively or additionally, the housing can alsobe configured in a raised fashion, that is to say have at least oneelevation, which can likewise correspond to the external shape of themedical user element, wherein, the medical user element, for the purposeof producing the assignment coupling, can be applied to the elevation.The medical user element can accordingly have a pocket and/or adepression corresponding to the elevation. Generally, in a very broaddefinition of the terms “depression” and “elevation”, the medical userelement and the control device can have mutually corresponding male andfemale connecting elements which can be used for producing theassignment coupling. In this way, the control device and the medicaluser element can be configured for example wholly or partly as “lock”and “key” (or vice versa) in terms of their external form, in order toenable an unambiguous assignment coupling which preferably cannot bebrought about inadvertently.

The depression can comprise a pocket, an insertion slot, a bulge, agroove or combinations of the aforementioned and/or other depressions.In some embodiments, the depression, in terms of its external shape,visually for the user, can be unambiguously assigned to the shape of themedical user element, such that a user intuitively recognizes that themedical user element has to be completely or partly inserted into saiddepression in order to bring about the assignment coupling and thus toinitiate the automatic assignment step automatically without performingfurther actions. In this way, incorrect operations can be furtherreduced or preferably completely avoided.

In this way or in some other way, it is possible to realize the “PairingBy Near Closing” already described above, which brings about thetemporary predefined coupling alignment. In this way, the control deviceand the medical user element can be prepared for an authenticationprocess during the assignment step.

A further possibility—which can likewise be used alternatively oradditionally—for the configuration of the medical system or theassignment coupling has already been discussed above. In this case, theassignment coupling comprises an exchange of biometric features.Accordingly, the control device and the medical user element in eachcase can have, for the purpose of the assignment coupling, for example,an interface in the form of one or more detection devices for detectingone or more biometric features of the user. As an alternative or inaddition to the actual user, in particular it is possible in this case,too, for a third person also to provide the biometric features in orderto obtain the assignment, for example a physician, a pharmacist, acare-giver, a spouse or a medical technician who sets up the medicalsystem for the user.

In this case, biometric features should generally be understood to meanunambiguous biometric information which can serve as assignmentidentification. Examples of such biometric features are a shape of aniris of the user, fingerprints or the like. For this purpose, thedetection device can comprise, for example, a fingerprint scanner, aniris scanner or similar detection devices, such that the same biometricfeature can be detected firstly by the medical user element and secondlyby the control device in order to assign them unambiguously to oneanother. The assignment coupling can then comprise a handling of themedical user element and of the control device by the user (oranalogously a third person), which can take place simultaneously orsuccessively, wherein the medical system is designed to initiate theassignment step upon recognition of the same biometric feature by thedetection device. The detected biometric feature therefore serves asassignment identification within the meaning of the above description orat least as part of said assignment identification. The handling by theuser is effected for example by means of a body part, for example ahand, wherein the biometric features can be detected, in particular afingerprint of the hand. In this case, the detection devices canpreferably be configured in such a way that the biometric feature is notdetected during normal operation, for example normal medical operation,for example by means of a corresponding covering and/or an arrangementat locations which usually do not come into contact with the relevantbody part.

The medical system can be designed, in particular, to automaticallystart medical operation wholly or in part upon or after successfulcompletion of the assignment step. For example, measurement operation ofa sensor can be started automatically. Further handling by a user is notnecessary in this case; rather, a genuine plug-and-play system ariseswhich can automatically commence its operation after the assignment stepand can exchange personal data, for example.

The medical system can comprise one or a plurality of medical userelements. If a plurality of medical user elements are provided, then thecontrol device and the medical user elements can form a medical network.This medical network can furthermore comprise further components, whichdo not come under the term medical user element or under the termcontrol device, such as, for example, devices which have no medicalfunction. Thus, an interface device and/or a storage device can beprovided in order to exchange data between the medical network and othercomponents, for example with other networks. In principle, the number ofcomponents to be assigned and/or the temporal assignment and order arenot limited or prescribed. Thus, a data logger module can optionally beprovided, for example for purposes of evaluating the personal dataand/or other data. Alternatively or additionally, the user can evaluatepersonal data collected by the medical user element, for example asensor, directly in a PC system with a physician by said data beingloaded onto the PC system (upload). This process can also requirepairing, for example with performance of an assignment step inaccordance with the above description. The medical system canfurthermore be designed to enable an automatic inclusion of furthermedical user elements by means of further automatic assignment stepswithin the meaning of the description above. In this way, the medicalnetwork can be extended according to the plug-and-play principle, but itcan always be ensured that personal data are exchanged only betweenelements assigned to one another, for example a specific control deviceand a specific medical user element.

As described above, the control device can comprise at least one userinterface for exchanging data and/or commands with the user, inparticular an indicator element and/or an operating element. The medicaluser element typically does not comprise such elements which enable theuser to directly access functions and/or data of the medical operatingelement, such that the medical user element can be configured forexample wholly or partly as a cost-effective disposable elementfashioned in a simple manner. In particular, the medical user elementcan also be configured without operating elements and/or indicatorelements, such that the medical system can be operated for examplecompletely via the control device. The control device can comprise atleast one data processing device, for example a microcomputer. The dataprocessing device can be designed to process the personal data at leastin part. Processing in this sense should generally be understood to meanstorage of the data, representation of the data for a user, indicationof trends or other measurement results, and at least partial analysis ofthe data (for example by filtering, evaluation or the like) or databasefunctions or combinations of the aforementioned or other processingfunctions. Alternatively or additionally, the user element can alsocomprise at least one data processing device, for example amicrocomputer and/or a microcontroller.

The control device can be configured, as described above, as a portablecontrol device and can comprise a mobile communication device, such as amobile radio device. Portable computers can also be encompassed, forexample PDAs (Personal Digital Assistant). In some embodiments, thecontrol device itself has at least one measurement function independentof the medical user element. In this case, an independent measurementfunction should be understood to mean a measurement function, that is tosay the detection of a physical and/or chemical and/or physiologicalproperty of the user, which is effected independently of a measurementcarried out by the medical user element. Although this can involve ameasurement variable which is likewise detected by the medical userelement, said measurement variable is detected independently by themedical control device. In particular, this measurement function can bea measurement function for detecting at least one property of the bodyof the user, for example a bodily function and/or an analyteconcentration. The control device can be a control device which isdesigned to qualitatively and/or quantitatively detect an analyte in abody fluid by mean of least one test element, for example a test stripand/or a test tape and/or a test dial. The medical system can bedesigned, in particular, to carry out a calibration measurement by meansof the measurement function of the control device, for example acalibration measurement on blood glucose. In particular, the controldevice can be designed to detect an analyte qualitatively orquantitatively in a blood sample, in particular a whole-blood sample.Thus, the control device can simultaneously be a measuring device forglucose from whole-blood. These measurement values can be used forexample as a reference measurement method. In this way it is possiblefor example to evaluate measurement signals which can be contained inthe personal data, for example, wherein calibration information obtainedby the control device is used during the evaluation.

The medical user element can be configured in various ways and comprisevarious medical functions. Thus, the medical user element can comprise asensor for detecting at least one analyte in a body fluid, in particulara sensor that can be implanted into a body tissue. By way of example,the sensor can be used in a continuous monitoring glucose system. Thesensor can comprise, for example, as explained above, one or moredisposables, one or more re-usables, read-out and data managementcomponents.

Alternatively or additionally, the medical user element can furthermorecomprise a measuring device for detecting at least one bodily function.Said measuring device can comprise one or more of the abovementionedsensors for qualitatively and/or quantitatively detecting the analyte inthe body fluid. However, other bodily functions can also be detected, inprinciple, such as, for example, body temperature, blood pressure or thelike. Once again alternatively or additionally, the medical user elementcan also comprise a medication device, that is to say a device which isable to deliver specific substances such as medicaments to the body.Insulin pumps, in particular, can be mentioned here as an example. Onceagain alternatively or additionally, the medical user element can alsocomprise one or more medical actuator devices comprising at least oneactuator for controlling a bodily function. Pacemakers, valves or thelike can be mentioned here as examples.

In the case of implantable sensors, the assignment coupling canimplemented in a non-implanted state. Alternatively, however, theassignment coupling can for example also be designed in such a way thatit is effected with a non-implanted part of the otherwise implantedsensor. The above-described embodiments in which the medical userelement does not have its own actuator system for directly signalingstates to the user and no input/output interface can be desired for usewith implantable sensors. Generally, it should be pointed out that themedical user element can also comprise for example a plurality offunctions, for example a plurality of measurement functions or combinedmeasurement functions and actuator functions.

The medical system can furthermore be designed in such a way thatinformation about one or more current and/or previous assignments isstored in the control device and/or the medical user element. By way ofexample, a pairing, that is to say an assignment, and/or aninstantaneous secure wireless communication connection can berepresented unambiguously on the control device. In this embodiment, theuser can rely on the fact that data or, in the case of an emergency alsoalarms can be transmitted securely. In this case, a pairing, anassignment and/or a secure communication connection can be represented.In addition, a setting-up with the aim of security can also be effectedin such a way as to make it recognizable to a user whether or not acommunication connection currently exists and/or whether saidcommunication connection is configured securely. For this purpose, it ispossible to provide, for example, one or more indicator elements ofoptical and/or acoustic and/or haptic and/or other type. One or moresymbols can be provided which enable a visual indication. Thus, the usercan see with the aid of a red or green luminous or flashing radio towersymbol or other symbol or hear by means of an acoustic indication (e.g.by virtue of different tones) whether a communication connectioncurrently exists securely (e.g. green illumination) or does not (e.g.red illumination). It is also possible to make it recognizable whetheror not the user can rely on the fact that a spontaneous alarm, forexample on account of hypoglycemia, is actually transmittedspontaneously. In this case, spontaneously can be understood to mean anear-instantaneous sequence, for example within a time period of lessthan one minute. This can prevent the user from mistakenly relying onsuch alarms being transmitted when in actual fact the connection, forexample a radio connection, is not currently provided, for example onaccount of disturbances, range problems or other technical problems,and/or an alarm does not get through.

The medical system can furthermore be designed to enable an automaticseparating step. This automatic separating step can prevent a furtherexchange of personal data between the medical user element and thecontrol device. This can mean, in particular, that the assignmentbetween the medical user element and the control device is canceled orun-paired.

In this case, the separating step should be effected in a defined mannerand initiated only under defined conditions as far as possible in justthe same way as the assignment step. Thus, an un-pairing should not beinitiated or confirmed merely by the actuation of a key or some othersimple actuating element, but rather in just as unambiguous a manner asthe pairing. In this way it is possible to prevent a situation in which,as a result of careless actuation of an actuating element, theassignment and hence the connection, for example, is interrupted andproblems, for example, can thus occur with regard to transmission ofdata in the case of an emergency or transmission of alarms. Inparticular, the un-pairing can be initiated by a user action whichdeviates considerably from an actuation of the medical system in normaloperation.

The separating step can be initiated by the above-described assignmentcoupling being brought about anew, for example in accordance with one ormore of the embodiments described above. In this respect, reference canonce again be made to the above description. The system can be designedsuch that when the assignment coupling is brought about anew, theassignment step is carried out anew and in this case is interpreted as aseparating step. Accordingly, reference can largely be made to the abovedescription of possible options. By way of example, a first instance ofbringing about the assignment coupling can be interpreted as initiationof a pairing and a second instance of bringing about the assignmentcoupling can be interpreted as initiation of the un-pairing, wherein, ifappropriate, further instances of bringing about assignment couplingscan be interpreted alternately as initiation of pairing and un-pairing.The system can furthermore be designed so that in each case the currentstate between a specific medical user element and the control device ismade recognizable for the user, for example via an indicator element.Thus, by way of example, on a display of the control device, it ispossible to indicate whether, with one or more medical user elementssituated in a range for a data exchange, there is pairing or un-pairing,that is to say whether or not an exchange of personal data can takeplace. Alternatively, an automatic separating step can also be initiatedby some other process, for example by pressing a key or the like.

The medical system can furthermore also comprise a failsafe concept,that is to say a concept which converts the medical system or one ormore components of the medical system to a safe state in an unexpectedsituation, for example an occurrence of a fault. By way of example, themedical user element and/or the control device, optionally also withoutthe possibility of audible or visual notification of the user, cancomprise one or more algorithms for being brought to a safe state when afault occurs. By way of example, the medical user element can bedesigned to establish the safe state when a fatal fault occurs, and, forexample, upon the next opportunity, to communicate the occurrence of thefault, the safe state or other information to the control device.Various other configurations of a failsafe concept in the context of theplug-and-play concept proposed are conceivable.

Further possible configurations of the medical system concern theexchange of data, for example the personal data or data which cancomprise the medical data. Thus, the freedom of movement of the user isintended to be restricted as little as possible by the data exchange,which, as described above, takes place wirelessly. Accordingly, the dataexchange should take place so rapidly that all the data to betransmitted are transmitted within the time within which the user movespast a control device in the course of normal movements, which can alsobe described as data transfer “by the way”. Typical movement speeds ofusers are approximately 1 m/s. Accordingly, the control device can beaccommodated in a stationary fashion and separately from the user,whereas the medical user element is connected to the user and movesalong with the latter. The connection set-up and the useful datatransmission should accordingly be effected within this time, thusresulting in typical data transmission rates of more than 100 kbit/s.

Since radio systems usually operate in physically undefinedenvironments, transmission links are disturbed in many cases. This canhave the effect that a transmission upon establishment of proximityunder unfavorable circumstances does not take place completely or elseis totally disturbed. In order to reduce this risk, in the medicalsystem proposed it is possible to transmit a temporal profile ofpersonal data, for example measurement values, in compartments. It isproposed that the medical system is designed to enable a repeatedexchange of complementary data records at least upon repeated momentaryestablishment of proximity between the control device and the medicaluser element in medical operation. By way of example, curveprogressions, that is to say a plurality of data points, can betransmitted, in which case a subset of the data records is respectivelytransmitted during each transmission process. Said subset can cover theentire region of the curve progression and/or of a time interval underconsideration, but with comparatively low temporal and/or dynamicresolution. By way of example, it is possible to transmit individualdata records which were recorded at equidistant temporal separations. Itis thus possible that although the curve progression is not representedwith complete accuracy, it is nevertheless represented qualitativelywell and completely, even if only one or a few transmission processestake place. Upon the next establishment of proximity, if appropriate, afurther but different subset of the data to be transmitted can then betransmitted, followed if appropriate by further transmission processes.Thus, a first, relatively short data packet already allows therepresentation and/or evaluation of a complete curve of the data pointsdetected until then, which becomes more accurate with each data record,up to complete transmission of the data record.

As explained above, alongside the medical system, a method for operatinga medical system, in particular a medical system in accordance with oneor more of the embodiments described above, is furthermore proposed. Inthis case, a control device and at least one medical user element areused. The medical user element and the control device are designed toexchange data wirelessly. In the method, an automatic assignment step iscarried out, wherein an exchange of personal data between the medicaluser element and the control device is enabled by the automaticassignment step. The automatic assignment step is automaticallyinitiated by means of an assignment coupling between the medical userelement and the control device. The assignment coupling is subsequentlyseparated again for medical operation of the medical system. For furtherpossible configurations of the method, reference can be made to theabove description.

The medical system and method proposed have numerous advantages overknown systems and methods. Thus, the above mentioned disadvantages ofknown systems, for example of continuously measuring self-monitoringdiabetes systems, can be largely avoided by means of the medical systemproposed, for example by means of consistent plug-and-play conceptions.In this case, the plug-and-play concept can relate to the entireinteractive action sequence between the medical system and the user.

The user can be enabled, in particular, just with elementary actionsteps, such as, for example, unpacking from a primary packaging,preparing the biological application, attaching the system to the bodyand carrying out an implantation, to start a subcutaneous continuousglucose measuring process and to keep it in operation. At the end of ameasurement cycle, a removal of the system or of the medical userelement can then be carried out manually. Generally, upon or after theremoval of the medical user element, for example the separating stepdescribed above, if appropriate, a data protection step canautomatically be instigated, in the course of which, for example,measurement data can be transmitted from the user element to the controldevice and, if appropriate, stored there.

The medical system can furthermore be embodied in such a way thatinsertion of subcomponents, for example data carriers, batteries or thelike, and/or data inputting and/or activation and initialization ofsequences by the user can largely be obviated. The medical system andthe components thereof can be embodied for example in such a way thatthey only have to be configured minimally by the user, for example onlyby settings of country languages and time zones. However, these steps,too, could optionally be performed automatically by the medical systemor individual components of the medical system, for example by theestablishment of spatial coordinates by means of GPS localization and/orby means of radio time systems. The reference to an exact time may, ifappropriate, be therapeutically important, for example in the case ofdiabetes with regard to the administration of active substances.Precisely when journeys are made, therefore, an automatic changeover ofthe time, for example a local time in relation to an absolute time, canbe important. The medical system can be designed to perform such anautomatic changeover. By way of example, a function of the medicalsystem, in particular a function of the medical user element, can becompletely or partly adapted to a local time, for example automatically.By way of example, a controlled delivery of medicaments or some othermedical function can be adapted to a local time, in particularautomatically, such that, by way of example, jetlag is not accompaniedby therapy-lag.

By means of the medical system, for example in the case ofself-monitoring diabetes systems, measurement values and results can beassigned to a defined user unambiguously and in the manner free oferrors. This is becoming increasingly important since systems of thistype nowadays are spatially distributed to an increased extent and areaccordingly made available to the public to an increased extent, forexample in the context of medical offices, communication media or thelike.

Moreover, the medical system affords the advantage that not only cansystem components and entire medical systems be started up anddeactivated in a simple manner, but that accordingly unambiguousassignments of two or more system components to one another can also beeffected in a simple manner by means of simple action sequences. Besidesthe unambiguity of the assignment, it can also be noted as advantageousthat the user is not restricted, or is restricted only to aninsignificant extent, by the proposed medical system in terms of saiduser's freedom of action and freedom of movement.

BRIEF DESCRIPTION OF THE DRAWINGS

Further details and features of embodiments of the invention will becomeapparent from the following description of certain exemplaryembodiments. In this case, the respective features can be realized bythemselves or as a plurality in combination with one another. Theinvention is not restricted to the exemplary embodiments. The exemplaryembodiments are illustrated schematically in the figures. In this case,identical reference numerals in the individual figures designateelements that are identical or functionally identical or correspond toone another with regard to their functions.

FIG. 1 shows an example of a medical user element in the form of animplantable sensor.

FIG. 2 shows the implantable sensor during implantation in a sectionalillustration from the side.

FIG. 3 shows a first exemplary embodiment of “pairing by near closing.”

FIG. 4 shows a second exemplary embodiment of “pairing by near closing.”

FIG. 5 shows an exemplary embodiment of pairing by using a dockingstation.

FIG. 6 shows pairing by recording biometric features.

FIG. 7 shows a data transmission from a moving user to a control devicethat is stationary or moving at a different speed.

FIG. 8 shows an example of a complementary data transmission.

FIG. 9 shows a schematic illustration of a coupling of a computer into amedical system.

DETAILED DESCRIPTION

A medical system embodiment according to the invention is describedbelow by way of example of a continuous monitoring glucose system. Asystem of this type comprises a sensor 110, which is illustratedsymbolically in FIGS. 1 and 2 and which has a disposable unit 112 and areusable unit 114. These units 112, 114 are illustrated schematically inFIG. 1. FIG. 2 illustrates a process of implantation of the sensor 110by means of an implantation aid 116, which, if appropriate, can beremoved again later.

The sensor 110 comprises a sensor 118 that can be inserted into the bodytissue, for example interstitial tissue. In this case, the disposableunit 112 and the reusable unit 114 are not illustrated in FIG. 2. By wayof example, after the sensor element 118 has been implanted into thebody tissue 120 of a user 122, the reusable unit 114 can be connected tothe disposable unit 112 via an interface 124 (see FIG. 1), in particulara pluggable hardware interface. The sensor 110 can furthermore comprisea sensor plaster 126, by means of which the sensor 110 can be stuck on askin surface of the user 122.

As emerges from the schematic illustration in FIG. 1, the sensor 110,for example the disposable unit 112, can comprise, for example alongsidea sensor unit 128 for recording measurement data, an energy store 130and, if appropriate, a data memory 132 for the buffer-storage of sensordata. The reusable unit 114 preferably does not have its own energystore and is supplied with electrical energy by the disposable unit 112.The reusable unit 114 can likewise comprise a data memory 134 and alsoan interface 136 for wireless data exchange with a control device, withfor example a radio interface. Furthermore, an interface 138 can beprovided, which can be completely or partly different than the interface136 and for which can be used for the automatic assignment stepdescribed below, which is also designated below as pairing. Via saidinterface 138 the assignment coupling described above can be effected,by means of which the assignment identification can be exchanged.

The sensor 110 illustrated in FIGS. 1 and 2 forms a medical user element140, which is assigned to a user 122 and can be carried continuously bysaid user, in particular directly on or in the body. As an elementarystep of handling the sensor 110, in the present example, the disposable112 is unpacked, said disposable 112 is connected to the reusable 114and the sensor element 118 is inserted into the body tissue 120. Thefunctional unit thus produced is therefore ready for operation and canbegin detecting measurement values automatically. The described unit ofthe sensor 110 then can operate autonomously providing information suchas personal data, in particular measurement data, times, results or thelike, but outwardly not visible. In order to further process andrepresent these measurement values, therefore, a control device 142 isrequired (see FIG. 3, for example). At least one control device 142 ofthis type and the at least one medical user element 140 together form amedical system 144. The control device 142 can comprise for example ameasuring device, for example a blood glucose measuring device.Alternatively or additionally, it can also comprise a data managerand/or further-processing computer systems.

The data exchange from the sensor 110, which in this case serves as ameasurement value detection module, toward the control device 142, inthis case the blood glucose measuring device, has to be configured insuch a way that this can be assigned unambiguously. A situation in whichdata from a neighboring system reach a non-authenticated memory and/oran incorrect indicator unit should be avoided at all events. In orderthat components are authorized for exchanging private data, before thebeginning of the operation of the medical system 144, a deliberateauthentication step should be carried out in the context of an automaticassignment step, which is also designated as pairing. In this step, byway of example, one or more device numbers, in particular unique devicenumbers, for example of the control device 142 and/or of the sensor 110,can be exchanged. These device numbers and/or other types of assignmentidentifications can be stored for example in one or more data memoriesin the control device 142 and/or the sensor 110, and, if appropriate,linkages can be produced. By way of example, a unique device number ofthe sensor 110 can be stored in the data memory 132, which number, ifappropriate, can be exchanged and used to establish a linkage in thecontrol device 142, for example, such that after the automaticassignment step has been carried out, for example, the control device142 knows that personal data can be exchanged with this specific sensor110. Although the automatic assignment step is intended to be carriedout in a very deliberate manner by the user 122, it is neverthelessintended not to have the potential for error of manual number or codeinputting.

In conventional point-to-point plug connections this can easily beensured since the user 122 in this case actively and consciouslyproduces the plug connection and, given correct construction, no signalscan be fed in or tapped off externally. This is not ensured, however, inthe case of optical connections and primarily in the case of radioconnections. However, cableless connections and specifically radioconnections nevertheless have numerous advantages with regard toflexibility and modularity of product concepts. In the case of thesensor 110 proposed, therefore, the abovementioned interface 136 isdesigned for wireless data exchange, in particular as a radio interface.

FIGS. 3 to 6 illustrate different examples of embodiments of medicalsystems 144 according to the invention and embodiments of automaticassignment steps. In each of these cases, an assignment coupling betweenthe control device 142 and the medical user element 140 that is to becoupled thereto is produced, by means of which at least one assignmentidentification can be exchanged between the control device 142 and themedical user element 140.

Thus, FIGS. 3 and 4 show different exemplary embodiments of a medicalsystem 144, in which the medical user element 140 and the control device142 are designed in terms of their external shape in such a way thatthey can be brought into a defined temporary coupling alignment relativeto one another, in which the abovementioned assignment coupling ispresent and hence the assignment step is initiated, in which, in turn,the at least one assignment identification can be exchanged. In bothcases, the control device 142 can for example again be configured as ablood glucose measuring device. The control device 142 has a housing146, which has a depression 148 adapted to the external shape of thesensor 110. Said depression 148 enables a positively locking connectionbetween the sensor 110 and the control device 142, which connection canbe brought about deliberately and temporarily by the user 122 in orderto produce the assignment coupling and thus to initiate the assignmentstep described above. In this case, the exemplary embodiments in FIGS. 3and 4 differ to the effect that in FIG. 3 the sensor 110 has alreadybeen implanted in the body tissue 120 of the user 122, and that thecontrol device 142 can only be placed from above onto the externallyaccessible part of the sensors 110, for example only onto the reusableunit 114. The latter can have for example a square or rectangular plan,to which the plan of the depression 148 can correspond, such that theuser can bring about an assignment orientation without majordifficulties. In the exemplary embodiment in accordance with FIG. 4, bycontrast, the depression 148 is configured as a pocket, into which thesensor 110 can be inserted by its narrow side.

In both cases, the assignment step is initiated by the assignmentcoupling illustrated in FIGS. 3 and 4 with the assignment orientationillustrated. In both cases, the assignment step or the initiationthereof by the production of the assignment coupling is designatedsymbolically by the reference numeral 150. Before the assignment step150 is carried out, the medical user element 140 and the control device142 are in a non-assigned state (“unpaired”), whereas after theassignment step 150 the two elements 140, 142 are in an assigned state(“paired”).

As explained above, the medical user element 140, for example the sensor110, has, a separate interface 138 for the assignment step. Thisseparate interface 138 can be designed as an interface that does notinvolve direct electrical coupling for a data exchange that does notinvolve direct electrical coupling. In an analogous manner, the controldevice 142 can have an interface 152, which is designed specifically forthe assignment step and which is preferably embodied separately from anoptional further interface 154 for the wireless data exchange, forexample a radio interface. In the coupling orientation illustrated, theinterfaces 138, 152 can in each case be oriented with respect to oneanother in such a way that they can exchange the assignmentidentification. The assignment step can be initiated and carried out inthis way.

FIG. 5 illustrates a further exemplary embodiment of the medical system144, in which the assignment coupling is effected by means of a couplingelement 156 in the form of a docking station 158. In this case, thedocking station 158 has one or two interfaces 160, to which the medicaluser element 140 and the control device 142 can be mechanically and/orelectrically connected successively or simultaneously. By means of saidinterfaces 160, a purely mechanical orientation of the control device142 and of the medical user element 140 with respect to one another canbe effected, for example for an optimized exchange of the assignmentidentification. In FIG. 5, in this case the interface 152 of the controldevice 142 is merely indicated symbolically. The assignmentidentification can be exchanged directly from the interface 138 to theinterface 152, as indicated in FIG. 5, or for example via a thirdinterface, which can be part of the docking station 158 and which canalso be embodied in multipartite fashion. In this way, the assignmentinformation can be exchanged by means of the docking station 158 ascoupling element 156.

A third possibility for the assignment coupling between the medical userelement 140 and the control device 142 is illustrated symbolically inFIG. 6. In this case, both the medical user element 140 and the controldevice 142 each have a detection device 162 and 164, respectively, fordetecting a biometric feature of the user. In this case, the biometricfeature is symbolically designated by the reference numeral 166 in FIG.6 and can comprise a fingerprint, for example. The detection device 162,164 can accordingly comprise a fingerprint scanner, for example in theform of a scanner array and a scanner line. Other biometric features 166can also be used. The assignment step is initiated by the usersuccessively applying the latter's fingerprint or the other biometricfeature 166 onto the detection device 162 and 164. If the biometricfeatures 166 match, then they function as assignment information andbring about an automatic pairing between the control device 142 and themedical user element 140. If the medical system 144 has detectiondevices 162, 164 of this type, then it is possible, if appropriate, todispense with separate interfaces 138, 152 for the assignment step sincethe detection devices 162, 164 in this case themselves act as interfacesof this type. The biometric features can for example be converted intodata, for example binary data, and, if appropriate, can be encryptedand/or stored, in particular as codes, in the individual modules, forexample in the medical user element 140 and/or in the control device142. Upon contact, the codes can be compared and, optionally, personaldata can then be exchanged in the event of identity. In this way, apermanently required pairing can be obviated and, if appropriate, alsoan un-pairing, since a pairing can be carried out automatically forexample upon every new communication set-up by means of a codecomparison.

The possible configurations illustrated in FIGS. 3-6 constitute only aselection of possibilities for how an assignment step can be initiatedby means of the assignment coupling. Thus, in FIGS. 3 and 4, forexample, the combination of an unambiguous and deliberate manual actionon the part of the user 122 is achieved by means of so-called “nearclosing”. For this purpose, the user 122 can bring for example thesensor 110, for example a patch-type sensor 110, so near to the controldevice 142, for example the blood glucose measuring device, that anunintentional physical contact with an unauthorized module is virtuallyimpossible. As indicated in FIGS. 3 and 4, this can for example also beeffected by means of momentary, at least partial insertion of themedical user element 140 into the depression 148, for example a housingpocket on the blood glucose measuring device. Some other geometricalconfiguration of the user element 140 and/or of the control device 142for preventing an unintentional assignment coupling is also possible, inprinciple. Thus, an unintentional assignment coupling can generally beprevented by mechanical forms of the control device 142 and/or of theuser element 140, for example lock-key forms.

After the assignment step has been carried out, said assignment couplingcan then be canceled again, the two components 140, 142 can be separatedagain, and normal medical operation can be initiated. In this medicaloperation, for example personal data and measurement data of the sensor110, can be exchanged between the medical user element 140 and thecontrol device 142, via the interfaces 136 and 154. Alternatively, asshown with reference to FIG. 5, an assignment can also be effected viathe docking station 150, into which the medical user element 140 and thecontrol device 142 can be momentarily introduced, for example placed. Ifsuch a positively locking connection arises, then it is possible toexchange data in digital form between the modules 140, 142 to beassigned to one another (that is to say to be paired), in other wordsfor example an assignment identification which carries out, confirms andconcludes the pairing process. The two components 140, 142 can then bephysically separated again and are henceforth assigned to one another(paired). This assignment can be effected for example until an active“un-pairing step” takes place, that is to say a separating process, forexample by means of renewed near closing, for example analogously to oneor more of the embodiments in FIGS. 3-6.

Since the sensor 110, for example, can be a high-impedanceelectrochemical sensor system, data exchange via direct electricalconnections is functionally critical in general. Therefore, anelectrically hermetic encapsulation of the sensor 110 should generallybe striven for. Therefore, one or both of the interfaces 136, 138 aredesigned for a data exchange by means of electromagnetic fields, inparticular the interface 138. However, the interface 136, too, which canalso be configured wholly or partly identically to the interface 138 inrespect of components, can be configured in this way. The data exchangein a manner not involving direct electrical coupling can be effected,for example, via spatially closely coupled wire coils (that is to sayinductively, in particular) and/or via insulated capacitor plates (thatis to say capacitively, for example) or by means of RFID. Alternativelyor additionally, an optical data exchange (for example via a lightbarrier) can also be effected, which presupposes a physical visualcontact. All of these methods which can be used for the assignment stepand which necessitate corresponding setting-up of the interface 138 forthe assignment step largely prevent unintentional pairing withcomponents randomly situated in the vicinity.

The medical system 144 can be designed in such a way that, apart fromthe actions described above, no further actions need be carried out bythe user 122. However, further actions of this type can optionally beprovided. Thus, for further security of the method, the assignment stepcan also be initiated or enabled by the use of a further, independentfunction, such as pressing a key (for example on the control device 142and/or on the medical user element 140). A further possibility forreducing the probability of incorrect coding or incorrect allocation isa defined temporal code upon establishment of proximity of the twocomponents 140, 142. A unique assignment also allows the linkagedescribed with reference to FIG. 6 by means of biometric features 166,of the user 122, such as fingerprints, iris patterns or the like.However, this configuration generally means a comparatively great outlayon apparatus, which, however, in the context of the increasingprevalence of such safety systems (for example the availability ofcost-effective detection devices 162, 164), is both acceptable in termsof volume and economic in suitable orders of magnitude.

The number of components of the medical system 144 that are to beassigned to one another is not limited or prescribed, in principle.Thus, the medical system 144 can also be configured wholly or partly asa medical network and can optionally have for example a data loggermodule for evaluation purposes. Later, as indicated in FIG. 9, a usercan “upload” the personal data that have been collected by said user'ssensor 110 or medical user element 140 and have preferably been at leastbuffer-stored in the control device 142 directly to a computer system,for example a PC system 168, for example a PC system 168 of a physician.This can be effected, for example, as indicated in FIG. 9, via anadditional interface 170, which is shown here by way of example as awire-based interface, for example as an RS232 interface. In this way,the PC system 168 can be incorporated for example into the medicalsystem 144, for example for a short time. This incorporation can forexample likewise necessitate a pairing, but can also be effected withoutan assignment step, particularly when wire-based interfaces 170 areused.

The medical system 144 can also optionally be configured at least inpart as an open system and to enable interoperability. Thus, a physicianin principle generally cannot adapt to all possible patient-specific orproduct-specific pairing interfaces, since, for example, a multiplicityof competing products can exist. Accordingly, the medical system 144 canenable for example the incorporation of a specially authorized person orof a specially authorized system component, for example a physicianand/or a physician's computer, which can enjoy a special status. Thus, aspecial mode “physician” can be provided, for example in a radio system.In this special mode, a pairing with the specially authorized personand/or the specially authorized system component could be restricted tosoftware. This could be effected in such a way that a cross-manufacturerconvention is adopted which is understood by any medical system 144and/or the components thereof. In this regard, reference can be made tothe above-cited standard IEEE 11073 which can therefore be combined witha medical system 144 according embodiments of the invention.

After pairing has been effected, for example after the steps describedwith reference to FIGS. 3-6 have been carried out, components of themedical system 144 that can be assigned to one another exchange dataautomatically as soon as a transmission is physically possible. In thecase of typical sensors 110, this can be effected when proximity isestablished between the two interfaces 136, 154 to more thanapproximately 1 m. This distance may exist for example through arbitrarylayers of clothing. Physically, a transmission is possible, inprinciple, without spatial alignment and thus through a wide variety ofmaterials practically only by using radio waves. In principle, however,optical data transmissions can also be realized at least to a limitedextent in this medical operation.

If two components 140, 142 of a medical system that possibly communicatewith one another approach one another, then the medical system 144 canbe designed, in particular, in such a way that it automatically checkswhether an assignment of these components 140, 142 to one anotherexists, that is to say whether the latter are authorized for theexchange of personal data, in particular by means of a preceding pairingstep. This can be effected for example by means of communicationprotocols, for example in accordance with the OSI standard. Thus, bymeans of said communication protocols, for example, a stable contact canbe established, and it is possible to check whether an authorization(pairing) is present, and, if this is the case, the specific useful datacan then be exchanged uni-directionally or bi-directionally.

In order to comply with minimum restriction of the freedom of movementof the user 122, in medical operation, that is to say after carrying outthe pairing step or the assignment step, a data exchange between thecomponents 140, 142 of the medical system 144 that are assigned to oneanother and should be effected so rapidly that all the data to betransmitted are transmitted within the time within which a user 122normally moves past a control device not moving together with the user122. This data transmission can also be designated as “data transfer bythe way” and is illustrated symbolically in FIG. 7. By way of example,as indicated in FIG. 7, the user 122 can move at a speed of 1 m/srelative to the control device 142. This means that the connectionset-up and the transmission of personal data, such as useful data, forexample, should be effected within this time, which should result, asexplained above, for example in transmission rates of preferably morethan 100 kbit/s. Since radio systems operate in physically undefinedenvironments, however, the transmission links are often disturbed. Thishas the effect that transmission upon establishment of proximity, underunfavorable circumstances, does not take place completely or else istotally disturbed. In order to reduce this risk, the medical system 144can be designed, for example, in such a way that the personal data aretransmitted by single or repeated exchange of complementary datarecords. Thus, by way of example, it is possible to transmit temporalprofiles of measurement values in compartments. This is illustratedsymbolically in FIG. 8, where a set of signals S, for examplemeasurement values, are plotted as a function of a measuring instant t,for example the instants at which the measurement data were recorded bythe sensor 110. However, different types of data records than temporaldata records are also conceivable, in principle.

A curve progression 172 connects all the discrete data records in FIG. 8and thus maps the temporal profile of the detected signal as a functionof time t (i.e. S=f(t)) over a total observation period T. Theobservation period T is divided into N time intervals, for exampleequidistant time intervals. The data records in these time intervals aredesignated by the reference numerals 174, 176 and 178, for example, atthe respectively repeating positions in the intervals in FIG. 8.

In this case, a data record can be understood to mean a set ofalphanumeric characters enclosed by a so-called frame (start and/or enddefinition). By way of example, the partial data records designated bythe reference numerals 174, 176 and 178 in FIG. 8 can in each casecomprise a binary voltage value (S), the associated time (t) andoptionally further elements, for example one or more safeguard featuressuch as a CRC character. By contrast, a curve progression 172 can beunderstood to mean a connection of all the positions (S/t) described inthe data records or partial data records in a coordinate system, whichis ultimately tantamount to a closed representation of the functionS=f(t).

By way of example, the medical system 144 can be designed in such a waythat it firstly communicates the first partial data record 174 of theintervals 1 to N wirelessly upon establishment of proximity between user122 and control device 142. The wireless data exchange is designatedsymbolically by the reference numeral 180 in FIG. 7. If time then stillremains during the establishment of proximity, further partial datarecords 176, 178 of the intervals 1 to N can be transmitted.Alternatively, however, these can also be communicated to the controldevice 142 at later instants upon later instances of establishment ofproximity.

In this way, it is possible that although the curve progression isfirstly not represented with complete accuracy, it is neverthelessrepresented qualitatively well and completely by the first partial datarecord 174, which may, if appropriate, be therapeutically more important(e.g. in the event of hypoglycemia) than a high temporal and/or dynamicresolution. If time then still remains or in the context of a nextestablishment of proximity, further, different partial data records 176,178 can then be communicated. Thus, a first, relatively short datapacket in the form of a partial data record 174 already enables arepresentation of a well-approximated measurement curve of the curveprogression 172, for example on an indicator element 182 of the controldevice 142. With each communication of a partial data record 174, 176,178 the representation then becomes more accurate, up to the completetransmission of the curve progression 172. Between a first establishmentof proximity at an instant t_(i) and a further establishment ofproximity at an instant t_(n), in principle an arbitrary amount of timecan elapse, such that the data record detection has progressed and thenumber of intervals has increased to N+M. The intervals N+1 to M can befilled upon a second establishment of proximity, for example, firstlywith the partial data records 174 or directly with the partial datarecords 176, in the same way as the intervals less than N.Alternatively, however, other strategies for the data organization of acontinuous data acquisition are also possible.

The control device 142 is illustrated symbolically as a PDA in FIG. 7,with the indicator element 182 in the form of a display and one or moreoperating elements 184. Alternatively or additionally, however, thecontrol device 142 can also be configured as a blood glucose measuringdevice, for example, as has already been described above. Thus, thecontrol device 142 can be configured for example as a measuring devicefor glucose from whole blood. The measurement values of said measuringdevice can be used for example as a reference measurement method, forexample in order to calibrate the medical system 144. The whole-bloodmeasuring device may require, for example, similarly to the sensor 110,a data carrier that conveys batch-specific data from test elements tothe measuring device. This can be effected by the manual insertion of anelectronic data carrier into the measuring device.

However, alternatively or additionally, the control device 142 can alsobe configured as a data manager and can be coupled to a separate bloodglucose measuring device. Said separate blood glucose measuring devicecan then be introduced into the medical system 144 by means of aconventional technique or else by means of a corresponding plug-and-playtechnique, for example in accordance with the method according to theinvention.

A plurality of complete data records concerning medical user elements140, for example concerning disposable-reusable systems, can be storedin the control device 142, where they can be temporarily correlated forexample by means of real-time data, the blood glucose data and furtherevents. The data records can be read out and, if appropriate, processedfurther wholly or in part, likewise for example by means of a computerauthorized in a plug-and-play step, for example the PC system 168 inFIG. 9.

As explained above, the medical user element 140 preferably does nothave its own actuator system and/or input/output interface, for exampleits own display, for directly signaling to the user 122 states whichthen, if appropriate, are interpreted by said user or even should beinterpreted by said user. Thus, it is desired if the medical system 144ensures to an increased extent and actively that faults do not lead toincorrect measurement values. This can be realized for examplesubstantially by means of so-called “failsafe” functions, for examplewith sensor electrode monitoring, monitoring with regard to contactinterruption, monitoring of the operating voltages, monitoring of signalpatterns or similar fault monitorings. If the medical system 144 isstill operational in terms of its basic functions, for example withregard to the signal detection by means of the sensor 110 (for examplean optical and/or electrochemical analyte detection), a voltage supplyor telemetry, then it is possible to store the states of the medicaluser element 140, for example of the sensor 110, together with the datarecords of the personal data, for example in the data memory 132 and/orthe data memory 134. This status, if appropriate together with thepersonal data, for example the data record and/or curve progression 172,can then be stored, transmitted to the control device 142 and alsorepresented there, if appropriate, on the indicator element. Since,however, in particular the instant of the wireless data transmissiondoes not have to be close to the time of the actual event which led tothe recording of the data record and/or curve progression 172, or to thepoint in time of a malfunction, for example measurement data beset withfault messages in the status can be excluded from an indication. Ifappropriate, advice can also be issued to a user, for example once againby means of the indicator element 182.

In the broadest sense, additional monitoring can also be performed underthe plug-and-play method described above. Thus, monitoring of a properfit of the sensor 110, for example of a sensor/patch unit, could also beeffected, for example proper adhesion of the sensor plaster 126 on askin surface of the user 122. This is to be advocated particularly whenlong-term sensors 110 are used which are intended to yield measurementresults for example over a week or longer. In this way, by way ofexample, a sensor insertion site and/or a skin region beneath the sensorplaster 126, which generally cannot be seen from outside, can bemonitored and abnormal states can for example be detected and, ifappropriate, reported or communicated to a user 122. This could be donefor example by means of an optical and/or thermal sensor system that isseparate or integrated in the sensor 110. The data of said sensor systemcan also be contained in the personal data and become concomitantlycommunicated to the control device 142. In this way, the control device142 can issue corresponding warnings, for example, to the user.

Thus, embodiments of the medical system having plug-and-play functionare disclosed. One skilled in the art will appreciate that the teachingscan be practiced with embodiments other than those disclosed. Thedisclosed embodiments are presented for purposes of illustration and notlimitation, and the invention is only limited by the claims that follow.

1.-18. (canceled)
 19. A medical system for monitoring and/or controllingat least one bodily function of a user, comprising: a blood glucosemeasuring device; at least one device originating from a non-medicalarea, wherein either the blood glucose measuring device or the deviceoriginating from a non-medical area or both serve as a control device;and at least one medical user element embodied separately from thecontrol device, wherein the medical user element and the control deviceare configured to exchange data wirelessly, wherein the medical systemis configured to enable an exchange of personal data between the medicaluser element and the control device, and the enablement of the exchangeof personal data is in response to an automatic assignment step, whereinthe medical system is configured to automatically initiate the automaticassignment step in response to an assignment coupling between themedical user element and the control device, and wherein the medicalsystem is operable to perform a medical operation when the medical userelement is uncoupled from the control device.
 20. The medical system ofclaim 19 wherein the device originating from a non-medical area isselected from a group consisting of a mobile radio device, a sportdevice, a personal digital assistant, a smart phone, a pedometer, and apulse meter.
 21. The medical system of claim 19 wherein the medical userelement and the control device are configured to exchange datawirelessly using a body area network.
 22. The medical system as in claim19, wherein the assignment coupling comprises one or more of thefollowing couplings between the medical user element and the controldevice, a temporary predefined coupling alignment between the medicaluser element and the control device, wherein the coupling alignment isdifferent than an alignment in the medical operation; a temporaryphysical coupling connection between the medical user element and thecontrol device, in particular via a coupling interface, a dockingstation, a wire-based connection, a wireless near-field connection or aninfrared connection; and an indirect assignment coupling via at leastone coupling element, wherein the medical user element and the controldevice can be temporarily connected to the coupling elementsimultaneously or successively.
 23. The medical system as in claim 19,wherein the medical system is configured to exchange at least oneassignment identification via the assignment coupling, and wherein thecontrol device is designed to assign, in the medical operation, data, inparticular personal data, communicated by the medical user element onthe basis of the assignment identification to said medical user element.24. The medical system as in claim 19, wherein the medical user elementand the control device are configured in terms of their external shapeto enable a defined temporary coupling alignment between the medicaluser element and the control device.
 25. The medical system as in claim24, wherein the control device has a housing, wherein the housing has atleast one depression and elevation corresponding to an external shape ofthe medical user element, and wherein the medical user element, for thepurpose of producing the assignment coupling, temporarily can beintroduced into the depression and can be applied to the elevation. 26.The medical system as in claim 19, wherein the control device and themedical user element in each case have a detection device for detectinga biometric feature of the user, wherein the assignment couplingcomprises a handling of the medical user element and of the controldevice by the user, and wherein the medical system is designed toinitiate the assignment step upon recognition of the same biometricfeature by the detection devices.
 27. The medical system as in claim 19wherein the medical system is configured to automatically start themedical operation upon or after successful completion of the assignmentstep.
 28. The medical system as in claim 19 wherein a plurality ofmedical user elements are provided and the control device and themedical user elements form a medical network.
 29. The medical system asin claim 19 wherein the medical system is configured to enable anautomatic inclusion of further medical user elements by means of furtherautomatic assignment steps.
 30. The medical system as in claim 19wherein the control device comprises at least one data processing deviceand the data processing device is configured to process the personaldata at least in part.
 31. The medical system as in claim 19 wherein thecontrol device has at least one measurement function independent of themedical user element.
 32. The medical system as in claim 19 wherein themedical user element comprises one or more of the following elements, asensor for detecting at least one analyte in a body fluid that can beimplanted into a body tissue, a measuring device for detecting at leastone bodily function; and an insulin pump, and a medical actuator devicecomprising at least one actuator for controlling a bodily function. 33.The medical system as in claim 19, wherein the medical system is furtherconfigured to enable an automatic separating step, and wherein a furtherexchange of personal data between the medical user element and thecontrol device is prevented by the automatic separating step.
 34. Themedical system as in claim 19 wherein the medical system is configuredto exchange complementary data records at least upon repeated momentaryestablishment of proximity between the control device and the medicaluser element in the medical operation.
 35. The method system as in claim19 wherein the medical system is operable to perform a medical operationwhen the medical user element is uncoupled from the control device andpersonal data is exchanged during the medical operation.